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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

IAP Catheter — Class IIa MDD by Spiegelberg GmbH & Co. KG

MD Atlas
Spiegelberg GmbH & Co. KG

EUDAMED last updated this device on Apr 28, 2026

IAP Catheter

B-04260125712707

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Spiegelberg GmbH & Co. KG
UDI-DI code: 04260125712707
Reference / catalog number: SND32.1.11

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Manufacturer information

Organization name: Spiegelberg GmbH & Co. KG
SRN: DE-MF-000000008
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 8, 2011	Still on market

Device identification

Trade name: IAP Catheter
UDI-DI code: 04260125712707
Basic UDI-DI: B-04260125712707
Reference / catalog number: SND32.1.11
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The IAP catheter is used to measure intra-abdominal pressure (IAP) with an air chamber attached to the proximal tip of a double-lumen catheter. One lumen transmits the pressure to the ICP monitor. The second lumen serves to accommodate a guide wire.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U050402INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

1000265951Issued
Technical documentationNotified body: 0297Expiry: Oct 22, 2030
1000265927Issued
Quality management systemNotified body: 0297Expiry: Mar 20, 2029
1000216002Issued
Technical documentationNotified body: 0297Expiry: Mar 12, 2030
1000210544Issued
Technical documentationNotified body: 0297Expiry: Mar 20, 2029